A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

NCT06024746 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 202303CPC
• Study Type: interventional
• Target: 1,500
• Locations: 8 countries
• Sites: 104

Brief Summary

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Conditions

Heart Failure

Keywords

Heart Failure; Hospitalized

Outcome Measures

Primary Outcomes (3)

• Clinical benefit

  Hierarchical composite of the following: * Time to all-cause mortality * Number of total HF events * Time to first HF event * Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method

  6 months

• Number of serious adverse events (AEs).

  \- Serious AEs (excluding efficacy endpoints).

  6 months

• Number of adverse events leading to discontinuation of study drug.

  \- AEs leading to discontinuation of finerenone or empagliflozin.

  6 months

Secondary Outcomes (3)

• Time to first death from any cause or HF event.

  6 months

• Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).

  6 months

• Number of HF events from baseline to Day 90.

  90 days

Study Arms (2)

Finerenone plus empagliflozin

EXPERIMENTAL

Drug: Finerenone; Drug: Empagliflozin

Usual care

NO INTERVENTION

Usual care management

Interventions

Finerenone DRUG

Oral finerenone.

Finerenone plus empagliflozin

Empagliflozin DRUG

Oral empagliflozin.

Finerenone plus empagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
• Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
• Current hospitalization or recently discharged with the primary diagnosis of heart failure
• Heart failure signs and symptoms at the time of hospital admission
• Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission
• Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)
• Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).
• Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

You may not qualify if:

• Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis
• Documented prior history of severe hyperkalemia in the setting of MRA use
• Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i
• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² and/or potassium \>5.0 mmol/L
• Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
• Prior or planned heart transplant
• Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure
• Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
• Probable alternative cause of participant's heart failure symptoms
• Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
• Known hypersensitivity to the IP (active substance or excipients)
• Any other condition or therapy which would make the patient unsuitable for this study

Sponsors & Collaborators

• Colorado Prevention Center: lead
• Saint Luke's Mid America Heart Institute: collaborator
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (104)

CON-10004 Fairhope, AL Investigational Site

Fairhope, Alabama, 36532, United States

RECRUITING

CON-10075 El Centro, CA Investigational Site

El Centro, California, 92243, United States

RECRUITING

CON-10024 Sacramento, CA Investigational Site

Sacramento, California, 95816, United States

RECRUITING

CON-10023, San Francisco, CA

San Francisco, California, 94118, United States

RECRUITING

CON-10109, Van Nuys, CA

Van Nuys, California, 91405, United States

RECRUITING

CON-10001, Aurora, CO

Aurora, Colorado, 80045, United States

RECRUITING

CON-10005, Denver, CO

Denver, Colorado, 80204, United States

RECRUITING

CON-10078, Hialeah, FL

Hialeah, Florida, 33012, United States

RECRUITING

CON-10105, Miami, FL

Miami, Florida, 33135, United States

RECRUITING

CON-10113, Miramar, FL

Miramar, Florida, 33027, United States

RECRUITING

CON-10022 Atlanta, GA Investigational Site

Atlanta, Georgia, 30303, United States

RECRUITING

CON-10021, Glenview, IL

Glenview, Illinois, 60026, United States

RECRUITING

CON-10041, Island Lake, IL

Island Lake, Illinois, 60042, United States

RECRUITING

CON-10025, Naperville, IL

Naperville, Illinois, 60540, United States

RECRUITING

CON-10019, Peoria, IL

Peoria, Illinois, 61603, United States

RECRUITING

CON-10064, Merrillville, IN

Merrillville, Indiana, 46410, United States

RECRUITING

CON-10080, Lexington, KY

Lexington, Kentucky, 40503, United States

RECRUITING

CON-10086, Louisville, Kentucky

Louisville, Kentucky, 40205, United States

RECRUITING

CON-10079, Paducah, KY

Paducah, Kentucky, 42003, United States

RECRUITING

CON-10030 Baton Rouge, LA Investigational Site

Baton Rouge, Louisiana, 70808, United States

RECRUITING

CON-10090, West Monroe, LA

West Monroe, Louisiana, 71291, United States

RECRUITING

CON-10002 Kansas City, MO Investigative Site

Kansas City, Missouri, 64111, United States

RECRUITING

CON-10018, Omaha, NE

Omaha, Nebraska, 68105, United States

RECRUITING

CON-10318, Charlotte, NC

Charlotte, North Carolina, 28207, United States

RECRUITING

CON-10119, Centerville, OH

Centerville, Ohio, 45459, United States

RECRUITING

CON-10051, Chattanooga, TN

Chattanooga, Tennessee, 37403, United States

RECRUITING

CON-10045 Amarillo, TX Investigational Site

Amarillo, Texas, 79106, United States

RECRUITING

CON-10015 Austin, TX Investigational Site

Austin, Texas, 78705, United States

RECRUITING

CON-10304, Denison, TX

Denison, Texas, 75020, United States

RECRUITING

CON-10301, Fort Worth, TX

Fort Worth, Texas, 76104, United States

RECRUITING

CON-10085, Houston, TX

Houston, Texas, 77030, United States

RECRUITING

CON-10305, Layton, UT

Layton, Utah, 84041, United States

RECRUITING

CON-10009, Norfolk, VA

Norfolk, Virginia, 23507, United States

RECRUITING

CON-21036, Rio Branco, Acre

Rio Branco, Acre, 69915-030, Brazil

RECRUITING

CON-21064, Arapiraca, Alagoas, Brazil

Arapiraca, Alagoas, 57315-745, Brazil

RECRUITING

CON-21017, Linhares, Espirito Santo

Linhares, Espírito Santo, 29900-010, Brazil

RECRUITING

CON-21032, Salvador, Bahia

Salvador, Estado de Bahia, 40050-410, Brazil

RECRUITING

CON-21028, Brasilia, Distrito Federal

Brasília, Federal District, 70390-700, Brazil

RECRUITING

CON-21053, Aparecida de Goiânia, Goias

Aparecida de Goiânia, Goiás, 74936-600, Brazil

RECRUITING

CON-21003 Goiania, Goias Investigational Site

Goiânia, Goiás, 74453-200, Brazil

RECRUITING

CON-21020, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, 30180-080, Brazil

RECRUITING

CON-21051, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, 30220-140, Brazil

RECRUITING

CON-21013, Belo Horizonte, Minas Gerais

Belo Horizonte, Minas Gerais, 30441-070, Brazil

RECRUITING

CON-21009, Poços de Caldas, Minas Gerais

Poços de Caldas, Minas Gerais, 37706, Brazil

RECRUITING

CON-21056, Curitiba, Paraná

Curitiba, Paraná, 80060-900, Brazil

RECRUITING

CON-21038, Curitiba, Paraná

Curitiba, Paraná, 80230-130, Brazil

RECRUITING

CON-21047, Londrina, Paraná

Londrina, Paraná, 86038, Brazil

RECRUITING

CON-21001, Recife, Recife

Recife, Recife, 50720-110, Brazil

RECRUITING

CON-21016, Rio De Janeiro, Rio De Janeiro

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

RECRUITING

CON-21014, Rio de Janeiro, Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 22240-006, Brazil

RECRUITING

CON-21024, Natal, Rio Grande do Norte

Natal, Rio Grande do Norte, 59020-500, Brazil

RECRUITING

CON-21008, Caxias do Sul, Rio Grande do Sul

Caxias do Sul, Rio Grande do Sul, 95070560, Brazil

RECRUITING

CON-21042, Passo Fundo, Rio Grande do Sul

Passo Fundo, Rio Grande do Sul, 99010, Brazil

RECRUITING

CON-21007 Joinville, Santa Catarina Investigational Site

Joinville, Santa Catarina, 89200-000, Brazil

RECRUITING

CON-21058, Aracaju, Sergipe

Aracaju, Sergipe, 49055-210, Brazil

RECRUITING

CON-21057, Atibaia, São Paulo

Atibaia, São Paulo, 12944-060, Brazil

RECRUITING

CON-21004 Braganca Paulista, Sao Paulo Investigational Site

Bragança Paulista, São Paulo, 12916542, Brazil

RECRUITING

CON-21005, Itaquera, São Paulo

Itaquera, São Paulo, 08270-120, Brazil

RECRUITING

CON-21010, Osasco, São Paulo

Osasco, São Paulo, 06013-070, Brazil

RECRUITING

CON-21011, Presidente Prudente, São Paulo

Presidente Prudente, São Paulo, 19050-680, Brazil

RECRUITING

CON021043, Santo André, São Paulo

Santo André, São Paulo, 09090-790, Brazil

RECRUITING

CON-21074, São Paulo, São Paulo

São Paulo, São Paulo, 01229-010, Brazil

RECRUITING

CON-21062, São Paulo, São Paulo

São Paulo, São Paulo, 01317-002, Brazil

RECRUITING

CON-21037, São Paulo, São Paulo

São Paulo, São Paulo, 01323-001, Brazil

RECRUITING

CON-21048, São Paulo, São Paulo

São Paulo, São Paulo, 04004-30, Brazil

RECRUITING

CON-21049 Sao Paulo, Sao Paulo Investigational Site

São Paulo, São Paulo, 05652-900, Brazil

RECRUITING

CON-21031, Votuporanga, São Paulo

Votuporanga, São Paulo, 15505-189, Brazil

RECRUITING

CON-11011, Edmonton, AB

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

CON-11012 Surry, BC Investigational Site

Surrey, British Columbia, V3V OC6, Canada

RECRUITING

CON-11016, Sudbury, ON

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

CON-11010, London, ON

London, Ontario, N6A 5A5, Canada

RECRUITING

CON-11007 North York, ON Investigational Site

North York, Ontario, M6B 3H7, Canada

RECRUITING

CON-11008, Toronto, ON

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

CON-11019, Toronto, ON

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

CON-11001, Toronto, ON

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

CON-11026, Montreal, Quebec

Montreal, Quebec, H2X 1R9, Canada

RECRUITING

CON-11005 Sherbrooke, QC Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

CON-56002, Guangzhou, Guangdong province

Guangzhou, Guangdong, 510080, China

RECRUITING

CON-56008, Changsha, Hunan

Changsha, Hunan, 410011, China

RECRUITING

CON-56004, Jinan, Shandong Province

Jinan, Shandong, 250001/250021, China

RECRUITING

CON-56001, Shanghai, Shanghai

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

CON-56009, Shanghai, Shanghai

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

CON-56005, Taiyuan, Shanxi province

Taiyuan, Shanxi, 030027, China

RECRUITING

CON-56006, Xi'an city, Shanxi Province

Xi’an, Shanxi, 710038, China

RECRUITING

CON-56007, Chengdu City, Sichuan Province

Chengdu, Sichuan, 610072, China

RECRUITING

CON-56003, Tianjin, Tianjin

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

CON-56010, Hangzhou, Zhejiang Province

Hangzhou, Zhejiang, 311200, China

RECRUITING

CON-51006, Ahmedabad, Gujarat

Ahmedabad, Gujarat, 380005, India

RECRUITING

CON-51013, Bangalore, Karnataka

Bangalore, Karnataka, 560002, India

RECRUITING

CON-51009, Nagpur, Maharashtra

Nagpur, Maharashtra, 440033, India

RECRUITING

CON-38008, Santiago de Compostela, Galicia

Santiago de Compostela, Galicia, 15706, Spain

RECRUITING

CON-38002, Madrid, Madrid

Madrid, Madrid, 28034, Spain

RECRUITING

CON-38011, Madrid, Madrid

Madrid, Madrid, 28046, Spain

RECRUITING

CON-38012, Malaga, Malaga

Málaga, Malaga, 29010, Spain

RECRUITING

CON-38009, Manises, Valencia

Manises, Valencia, 46940, Spain

RECRUITING

CON-38001, Valencia, Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

CON-54001, Kandy, Central Province

Kandy, Central Province, 2000, Sri Lanka

RECRUITING

CON-54005, Colombo, Western Province

Colombo, Western Province, 01000, Sri Lanka

RECRUITING

CON-54007, Colombo, Western Province

Colombo, Western Province, 10350, Sri Lanka

RECRUITING

CON-54008, Ragama, Western Province

Ragama, Western Province, 11010, Sri Lanka

RECRUITING

CON-39010, Bournemouth, Dorset

Bournemouth, Dorset, BH7 7DW, United Kingdom

RECRUITING

CON-39002, London, UK

London, UK, SW17 0QT, United Kingdom

RECRUITING

CON-39007, Bristol, UK

Bristol, BS10 5NB, United Kingdom

RECRUITING

CON-39001, Glasgow, UK

Glasgow, G4 0SF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

finerenone; empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Marc Bonaca

CONTACT

(303) 860-9900; info@cpcmed.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 6, 2023
• Study Start: July 9, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10); BR (34); US (33); GB (4); CN (10); IN (3); ES (6); SR (4)